Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

NCT02755831 | Completed Results FDA Device

• 1 other identifier: NMCSD.2016.0029
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.

Conditions

Obstructive Sleep Apnea

Keywords

OSA; pregnancy; adverse pregnancy outcomes; continuous positive airway pressure; preeclampsia; gestational diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Pregnancy Outcomes

  Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)

  time of delivery

Secondary Outcomes (4)

• Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)

  early pregnancy (6-16 weeks)

• Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)

  27-33 weeks

• Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group

  8-12 weeks postpartum

• Hospital Costs at Time of Delivery

  Hospital costs at time of delivery

Study Arms (2)

Sleep Study + CPAP group

EXPERIMENTAL

Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment

Device: CPAP

Standard Prenatal Care group

OTHER

Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.

Other: Pre-natal care

Interventions

CPAP DEVICE

Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea

Sleep Study + CPAP group

Pre-natal care OTHER

Standard Pre-Natal Care

Standard Prenatal Care group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction.
• Between 6 and 16 weeks gestation at time of enrollment.

You may not qualify if:

• Current diagnosis and treatment of OSA.
• Patient refusal to randomization.
• Permanent Pacemaker (interfere with WATCHPAT sleep study).
• Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
• Coronary artery disease or congestive heart failure or cardiomyopathy.
• Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
• Inability to read or understand the consent.
• \<18 years of age.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center

San Diego, California, 92134, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pre-Eclampsia; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: CAPTAIN Dennis Spence, NC, USN, PhD, CRNA
• Organization: Naval Medical Center San Diego

dennis.l.spence.mil@mail.mil

6199161680

Study Officials

• Dennis L Spence, PhD

  United States Naval Medical Center, San Diego

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Nurse

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: April 29, 2016
• Study Start: February 20, 2017
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)